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    Qa Compliance Lead Auditor (Pv Quality Compliance)

    Fortrea
    2+ years
    Not Disclosed
    Mumbai Pune
    10 Nov. 8, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    About Fortrea
    Fortrea is a leading global contract research organization (CRO) with a dedication to scientific rigor and decades of experience in clinical development. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in 90+ countries, Fortrea is committed to transforming drug and device development, driving innovation, and ensuring rapid delivery of life-changing therapies for patients worldwide.

    Position Overview

    Fortrea is seeking a Global QA Lead Auditor to lead and manage regulatory audits and quality initiatives, ensuring global compliance and operational efficiency. The successful candidate will take charge of audit activities, provide subject matter expertise, and manage regulatory inspections while promoting process improvements and quality metrics across the organization.

    Key Responsibilities

    • Audit Management: Lead and conduct audits/inspections, including regulatory inspections and strategic client audits, ensuring compliance with GXP and applicable regulations.
    • Global QA Policy Development: Develop and lead global QA policies related to regulatory compliance, influencing and guiding the organization on niche regulatory topics.
    • External Audits/Inspections: Host external audits/inspections (e.g., for cause, non-standard authority inspections, country-specific inspections) and facilitate responses to audit findings.
    • Quality Metrics & Reporting: Lead the reporting of quality metrics and implement corrective actions or process improvements to enhance organizational compliance and efficiency. This includes reporting through forums such as Monthly Reports and Site Quality Reviews.
    • Regulatory Compliance: Ensure adherence to Regulatory Compliance and Quality Assurance (RC&QA) responsibilities outlined in controlled documents.
    • Process Improvement: Lead or participate in global quality initiatives aimed at improving compliance, efficiency, and the overall effectiveness of the QA organization.
    • Client & Stakeholder Communication: Act as a subject matter expert and provide strategic communication and guidance to clients, internal stakeholders, and regulatory authorities.
    • Backup for QA Manager: Serve as a backup for the QA Manager, providing monthly reports of activities, and taking on other related duties as assigned.
    • Continuous Improvement: Actively identify and implement process improvements that enhance overall audit quality, efficiency, and client satisfaction.

    Qualifications

    Experience:

    • 8+ years in a regulatory environment with specific expertise in GXP roles.
    • Proven experience as a Lead Auditor, with in-depth knowledge of relevant regulations.
    • Strong background in regulatory compliance and quality assurance processes.
    • Experience in strategic communication with clients and regulatory authorities.
    • Demonstrated experience in leading process improvement initiatives.

    Education:

    • Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related discipline.
    • Postgraduate degree (MSC or equivalent) in science or management-related disciplines is preferred, though experience may be substituted for educational requirements.

    Why Join Fortrea?

    Fortrea offers a dynamic and collaborative environment where problem-solvers thrive. As part of our team, you'll have the opportunity to make a meaningful global impact and contribute to the success of clinical trials that lead to life-saving therapies. Our commitment to innovation, excellence, and personal growth ensures that you'll be at the forefront of transforming the clinical development process.

    For more information about Fortrea and to explore other career opportunities, visit www.fortrea.com.

    Equal Opportunity Employer

    Fortrea is an Equal Opportunity Employer and is committed to creating an inclusive and diverse workforce. We do not tolerate discrimination or harassment of any kind and make employment decisions based on individual qualifications and the needs of our business.

    Fortrea is an EOE/AA employer, encouraging applicants from all backgrounds to apply. We make hiring decisions based on merit and qualifications, without regard to race, religion, color, national origin, gender, age, disability, veteran status, or any other legally protected characteristic.

    Privacy Statement

    For more information on how we collect, store, and process your personal data, please review our Privacy Statement.

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    Bucharest |

    Makkah :

    Riyadh | Jeddah | Khulais | Najran | King Abdullah Economic City | Rabigh |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |